Promoting Change in Practice for Respiratory Failure

NCT07519941 | Not Yet Recruiting

• 1 other identifier: 1R01HL157361
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 300,000 Hispanic individuals experience respiratory failure each year in the U.S. Hispanic patients are twice as likely to die from respiratory failure as non-Hispanic patients. There is an urgent need to identify and remediate mechanisms that increase risk of death from respiratory failure. The team's preliminary work identified two potential mechanisms: Hispanic patients with respiratory failure are more likely to be deeply sedated and less likely to receive physical therapy than non-Hispanic patients, which are both associated with mortality and poor long-term functional outcomes. The overall objective of this proposal is to improve outcomes for patients with respiratory failure through changes in intensive care unit (ICU) practice. This trial will refine and pilot an intervention to promote guideline-concordant care. The team's preliminary intervention will be iteratively refined through patient, family, and clinician engagement and piloted at two U.S. ICUs. The outcome of this study will be an intervention aimed at reducing mortality from respiratory failure.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability

  The co-primary endpoints are acceptability and feasibility. We will measure acceptability and feasibility in surveys using construct definitions from the Consolidated Framework for Implementation Research (CFIR) .

  From enrollment to 3 months

Secondary Outcomes (1)

• Patient safety culture score

  Enrollment through 3 months.

Other Outcomes (1)

• Implementation barriers and facilitators

  Enrollment through 3 months

Study Arms (1)

Safer sedation bundle

EXPERIMENTAL

This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain.

Other: Safer sedation bundle

Interventions

Safer sedation bundle OTHER

This is a unit-level quality improvement intervention to facilitate evidence-based sedation delivery. The quality improvement intervention consists of identification of a safe sedation champion among clinical staff, initiation of sedation rounds, and tools to facilitate structured assessment of sedation depth, delirium, and pain.

Safer sedation bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include physicians, nurses, and other staff at participating ICUs who consent to participate.

You may not qualify if:

• We will exclude potential participants who cannot speak either English or Spanish.

Sponsors & Collaborators

• New York University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mari Armstrong-Hough, PhD, MPH

  New York University School of Global Public Health

  PRINCIPAL INVESTIGATOR

• Thomas Valley, MD, MSc

  University of Colorado Anschutz School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsea Chobany, MPH

CONTACT

212-992-3723; chelsea.chobany@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-04